Field of the Invention
The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of an antibody that specifically binds interferon alpha receptor 1 (IFNAR1) or an antigen-binding fragment thereof. In embodiments, the antibody formulation comprises anifrolumab or an antigen-binding fragment thereof.
In some embodiments, the invention relates to a stable antibody formulation comprising about 100 mg/mL to about 200 mg/mL of an antibody or fragment thereof that specifically binds IFNAR1, about 25 mM to about 130 mM of lysine or a lysine salt; an uncharged excipient; a surfactant; and a formulation buffer. In some embodiments, the invention is directed to a container, dosage form and kit. In some embodiments, the invention is directed to a method of making and using the stable antibody formulation.
Background
Antibodies have been used in the treatment of various diseases and conditions due to their specificity of target recognition, thereby generating highly selective outcomes following systemic administration. In order for antibodies to remain effective, they must maintain their biological activity during their production, purification, transport and storage. New production and purification techniques have been developed to provide for large amounts of highly purified monoclonal antibodies to be produced. However, challenges still exist to stabilize these antibodies for transport and storage, and yet even more challenges exist to provide the antibodies in a dosage form suitable for administration.
Denaturation, aggregation, contamination, and particle formation can be significant obstacles in the formulation and storage of antibodies. Due to the wide variety of antibodies, there are no universal formulations or conditions suitable for storage of all antibodies. Optimal formulations of one antibody are often specific to that antibody. Additionally, antibody formulations may need to be further tailored to a specific antibody depending on the concentration of the antibody, and/or a desired physical property, e.g., viscosity, of the antibody formulation. Antibody storage formulations are often a significant part of the research and development process for a commercial antibody.
Various methods have been proposed to overcome the challenges associated with antibody stability. For example, in some instances, the antibody is often lyophilized, and then reconstituted shortly before administration. However, reconstitution adds an additional step to the administration process, and could introduce contaminants to the formulation. Additionally, reconstituted antibodies could suffer from aggregation and particle formation. Thus, a need exists to provide stable antibody formulations that can overcome the challenges associated with transport and storage.